Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration

March 30, 2024 updated by: Metha Songthamwat, UdonThani Hospital

Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration : A Randomized Controlled Trial

This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a double blinded, placebo controlled study which compose of two arms. The treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. The control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. The outcome is to compare the visual analog pain score during and after procedure.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • UdonThani
      • Udon Thani, UdonThani, Thailand, 41000
        • UdonThani Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • female ageed 20 years to 60 years who have an indication for manual vacuum adpiration under intraveneous analgesia

Exclusion Criteria:

  • patient with allergic to lidocaine or history of allergic to lidocaine
  • patient with reproductive and urinary infection
  • patient with abnormal vital sign
  • patient with abnormal kidney and liver function test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10% lidocaine spray without adrenaline
4 puffs of 10% lidocaine spray without adrenaline apply on cervical os before manual vacuum aspiration
Drug: 10 % lidocaine spray without adrenaline
Pateint with indication for manual vacuum aspiration aged between 20-60 years will received a standard injection of pethidine along with 1% lidocaine spray without adrenaline on cervical os to compare pain scores with placebo. Along with measuring side effects immediately and 30 minutes after receiving 1% lidocaine without adrenaline.
Other Names:
  • 10% Xylocaine spray
Placebo Comparator: Placebo
4 puffs of normal saline apply on cervical os before manual vacuum aspiration
Other: Placebo
4 puffs of normal saline apply on cervical os before manual vacuum aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score during manual vauum aspiration
Time Frame: during surgery
The pain score using visual analog scale is used to assess the pain score during the manual vacuum aspiration during procedure (score 0-10), the 0 score is no pain and the 10 score is the maximum pain
during surgery
pain score after manual vauum aspiration
Time Frame: at 30 minutes postoperative
The pain score using visual analog scale is used to assess the pain score after the procedure (score 0-10) the 0 score is no pain and the 10 score is the maximum pain
at 30 minutes postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UdonThani Hospital

Investigators

  • Principal Investigator: PATTARIKAN MANAYING, UdonThani Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 30, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2566/081 I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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